A CLINICAL STUDY TO EVALUATE THE ROLE OF SHIVAGUTIKA IN PELVIC INFLAMMATORY DISEASE

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1 (eissn ) ORIGINAL RESEARCH ARTICLE A CLINICAL STUDY TO EVALUATE THE ROLE OF SHIVAGUTIKA IN PELVIC INFLAMMATORY DISEASE 1 VISHWESH B.N., 2 SHOBHA BHAT 1 Associate Professor, Department of Prasootitantra and Stri roga. SDM College of Ayurveda, Hassan, Karnataka Associate Professor, Department of Agadatantra. SDM College of Ayurveda, Udupi, Karnataka Corresponding author vishweshbn@gmail.com Access this article online: Published by Atreya Ayurveda Publications, Ilkal (India) All rights reserved. Received on: 05/01/2014, Revised on: 28/01/2014, Accepted on: 28/01/2014 Abstract: Background: Pelvic Inflammatory Disease is an infective condition of genital tract with symptoms like lower abdominal pain and tenderness, abnormal vaginal discharge, chills, and fever. Various yonivyapaths (Diseases of the female reproductive system), presenting the above said symptoms like adhodara shoola (Lower abdominal pain), shoola in maithuna (dyspareunia), jwara (fever) and yonisrava (discharge per vagina) include vatala (endometriosis), paripluta (pelvic inflammatory disease), mahayoni (genital organ prolapse) and so on. Aims and objectives: To evaluate the effect of an shivagutika in PID subjects with an intention to maximize its clinical effectiveness and hasten its integration into wider clinical practice. Materials and methods: Shivagutika was administered twice daily with honey after food intake for 60 days. The signs and symptoms of PID were graded before and during the course of treatment. In most of the cases, there was a progressive reduction in the symptoms with time, indicating the efficacy of the formulation in PID. Conclusion: Shiva gutika efficiently decreases the symptoms of PID, clinically controls infection and can be recommended in the management of Pelvic Inflammatory Disease. Keywords: Lower abdominal pain, Menstrual abnormalities, Pelvic Inflammatory Disease, Shivagutika, Vaginal discharge. Introduction: Pelvic inflammatory diseases are where fallopian tubes, ovaries, cervix or uterus are inflamed and infected 1. PID can develop following a casual abortion that may cause the uterus to rupture. A weak uterus and adhesions may cause future miscarriages for the woman. PID may also be caused by sexually transmitted infection such as Chlamydia or Gonorrhea. If PID goes untreated, it causes scarring around the inflamed organs, which leads to infertility, chronic pelvic pain and blocked fallopian tubes which make an ectopic pregnancy more likely 2. Symptoms of various yonivyapadas specially udavarta, vatala, sanipatika, paripluta, pittala resembles with pelvic inflammatory diseases with main symptom of pelvic pain. This can be considered as tridoshaja vyādhi with vata predominance. In this especially there is derangement of apana and vyana vayu 3. Anyhow sotha is produced in these conditions which Journal of Ayurveda and Holistic Medicine January, 2014 Volume 2 Issue 1 27

2 further aggravates the pain and suggests involvement of pitta dosa along with vata. In modern system of medicine, antimicrobials, analgesics, NSAIDs are often prescribed in the treatment of Pelvic inflammatory diseases 4. Gastrointestinal upsets which are increased by analgesics and antiinflammatory drugs which also produce headache, dizziness, drowsiness. There is a great scope of research to find out management with long lasting effect, to treat the entire feature complex with single regimen. The aim of this study is to find out a safe, potent, cost effective nonsurgical management for Pelvic inflammatory diseases. Materials and Methods: The study employed a single arm before-after clinical trial design. Patients who met entry criteria with Pelvic Inflammatory Disease were assessed for signs and symptoms prior to and during the course of the treatment. The approval from the institutional ethical committee was taken and informed consent from each patient obtained. Details of the drug: Shivagutika which is explained in Rasayana adhyaya of chakradutta 5 served as the trial drug in this study. Shivagutika with shilajith as its main ingredient is indicated for various types of yoniroga, arbuda, pradara and considered as rasayana. The pharmacological activity of Shilajit shows good antiinflammatory and analgesic properties which is recommended in PID. Hence it was selected as the trial drug in this study. The trial drug in this study, shivagutika was purchased from the market. Ingredients of Shivagutika : The ingredients of Shivagutika are explained in Table 1. Table 1: Ingredients of Shivagutika Sl. No. Name Latin name Quantity 1. Shilajith Bitumen 640 gms 2. Shunti Zingiber officinale 80 gms 3. Pippali Piper longum 80 gms 4. Katuka Picrorhiza kurroa 80 gms 5. Karkatashringi Pistacia integerrima 80 gms 6. Maricha Piper nigrum 80 gms 7. Vidarikanda Pueraria tuberose 40 gms 8. Talisapatra Abies webbiana 160 gms 9. Vamshalochana Bambusa arundinacea 20 gms 10. Patra Cinnamomum zeylanicum (leaves) 20 gms 11. Twak Cinnamomum zeylanicum (bark) 20 gms 12. Nagakesara Mesua ferra 20 gms 13. Ela Eletharia cardamomum 20 gms 14. Sesamum oil 80 ml 15. Sugar 640 gms Journal of Ayurveda and Holistic Medicine January, 2014 Volume 2 Issue 1 28

3 16. Ghee 160 gms 17. Honey 320 gms Setting and Sample: The study population consisted of 15 subjects with PID. The OPD of Prasuti Tantra, S.S. Hospital, Institute of Medical Sciences, Banaras Hindu University, Varanasi, served as settings for the study. Inclusion and exclusion criteria: Inclusion criteria : Patients of active reproductive/child bearing age, with symptoms of PID such as lower abdominal pain, abnormal vaginal discharge, low backache, menstrual abnormalities and dyspareunia, who have been diagnosed to have PID in the last 6-12 months and are ready to undergo relevant investigations and hospital admission. Exclusion criteria: Pregnant or unmarried women, patients suffering from any systemic disease like tuberculosis, hypertension, diabetes etc,with history of drug allergy and psychological disorders, patients having specific pathology of genital tract i.e. benign or malignant tumor, erosion of cervix etc, subjects with history of recent delivery or abortion and patients with acute PID who require hospitalization. Method of administration of the drug: Shivagutika (500mg) was administered twice daily with honey after food intake for sixty days. Study Variables: The primary study variables were the following: 1) Clinical signs and symptoms of PID. 2) USG Findings. A clinical signs and symptoms checklist was developed to measure the presence or absence of signs and symptoms of PID. (Pain abdomen, per vaginal discharge, Low back ache, dysmenorrhea, dyspareunia and tenderness in fornices). Ultrasonography of Pelvic organs was carried out for the presence of fluid collection in pouch of Douglas and to know the condition of adnexal uteri. High vaginal swab culture and sensitivity test was done for identification of specific organism. The symptoms were noted before the treatment began.(f1) The patients were then subjected to treatment, which included internal administration of Shivagutika (500mg) twice daily with honey after food for sixty days. 3 assessments were done in all the patients and the presence (mild / moderate) or absence of each of the above mentioned signs and symptoms were assessed during the course of treatment. First two follow up were at the interval of 15 days (F2 and F3) and last at the interval 30 days (F4). Thus total period of follow up was of 2 months. After stopping the administration of the drugs under trial patients were advised to report after 30 days for last follow up (F5). During the follow up study, further improvement or deterioration of the signs & symptoms were recorded. Observations: Among the 15 patients registered in the study, the incidence of PID was more in the age group yrs(32%), majority ones being house wives (85%), with larger percentage having irregular bowel habits (71%). Utmost percentage of patients were with gravidity 3 (32%), parity 2 (39%) and no history of abortion (53%).The age of menarche was 13-14yrs in 82% of patients, duration of menstrual bleeding 3-4 days in 60% of patients, amount of menstrual bleeding average in 64%. 35% of patients used barrier or safe period method for contraception. Frequency of sexual intercourse was 2-3 times/ week in 75% of patients. Pain in lower abdomen was absent in 14%, mild in 57% and moderate in 29% of Journal of Ayurveda and Holistic Medicine January, 2014 Volume 2 Issue 1 29

4 patients. Incidence of abnormal per vaginal discharge reported mild discharge in 29% of patients and moderate in 71%. Low backache score reported absent in 36%, mild in 57% and moderate in 7%of patients. Pain during menstruation was absent in 36%, mild in 36% and moderate in 28% of patients. 50% of the study subjects reported with Dyspareunia whereas it was absent in the other 50%. Tenderness in fornices was absent in 50% and present in the other 50%. The presence of positive finding of PID in USG was present in 57% and not present in the other 43%. Results: Effect of therapy on Clinical signs and symptoms of PID: Pain abdomen, Per vaginal discharge, Low back ache, Dysmenorrhea, Dyspareunia and Tenderness in fornices showed statistically significant reduction following treatment. The details of these are given in table no.2. During the follow up, there was one dropout and hence the statistical analysis was done for only 14 subjects. Table 2: Effect of therapy on Clinical signs and symptoms of PID Criteria BT% AT% Pain abdomen Score Vaginal discharge Low back ache Pain in Menstruation Dyspareunia Tender Fornices BT Mean ±SD Score Score Score Score Score Score Score Score Score Score Score Score Absent Present Absent Present AT Mean ±SD %of relief t t t p p<0.001 H.S p<0.001 H.S t p<0.02 H.S t p<0.01.h.s Z p<0.05.sig t p<0.02 H.S Effect of therapy on USG Findings: The presence of positive finding of PID in USG was noticed in 8 patients at first visit (57%). In 4 th follow up however it was present only in 2 patients (14%). Comparison of USG finding Journal of Ayurveda and Holistic Medicine January, 2014 Volume 2 Issue 1 30

5 between initial and last follow up showed significant values (p<0.05.s) as stated in table 3. Table 3: Effect of therapy on USG Findings USG findings BT % AT % % Relief Change Absent Present t 75 Z-2.44 p<0.05.sig. p Discussion: Women with symptomatic PID commonly have lower abdominal pain and tenderness (especially during coitus), abnormal vaginal discharge, chills, and fever. Therapeutic goals for treating PID are elimination of reproductive tract infection and inflammation, improvement of symptoms and physical findings, prevention or minimization of longterm squeal 6. Shilajatu, the main ingredient of shiva gutika has kashaya (astringent), amla rasa (sour taste), katu vipaka (pungent in biotransformation), anushnasheeta veerya (not to cold in potency) 7. It is useful in alleviating tridoshas (three humours). It possess rasayana (rejuvenation), vrishya properties (aphrodisiac) 8. It is useful in the treatment of prameha (diabetis mellitus), pandu (anemia), gulma (tumour), pleeharoga (splenic disordes), sthaulya (obesity), shotha (swelling), jvara (fever) etc. It is said that there is no such disease which cannot be cured with References: 1. D. Keith Edmonds. Dewhurts Textbook of Gyneacology. 7 th ed. Massachusetts,USA: Blackwell Publishing:2007.p Emans S.J., Laufer R.L., Goldstein, D.P. Pediatric & adolescent gynecology. 5 th ed. Philadelphia: Lippincott Williams & Wilkins: 2007.p Joshi N.G. Ayurvedic Concepts in Gynaecology. Jawahar Nagar. New Delhi: Chaukhamba Sanskrit Pratishthan: 1999.p B.S. Sengupta, S.K. Chattopadhyaya. D.C. Dutta. Gynaecology for Postgraduates & shilajatu 9. Shilajatu is also used as yogavaha as it increases efficacy of many drugs. Apart from this the other drugs in shivagutika have kaphavata shamaka property. Shilajatu has significant anti-inflammatory, analgesic, immuno modulatory, antiviral and antioxidant activity 10. Antimicrobial activities against staphylococcus aureus, escherichia coli and candida albicans and S. aureus and antifungal activity against alternaria cajani were identified 11. The above observations it is clear that shivagutika is a good drug of choice in the treatment of pelvic inflammatory disease. Conclusion: From the above clarifications it can be concluded that Shiva gutika efficiently decreases the symptoms of PID, clinically controls infection and can be recommended in the management of Pelvic Inflammatory Disease. Practitioners.Culcutta: B.I. Churchill Livingstone Pvt Ltd:2006.p J.P. Tripathi, editor, Chakradatta with Bhavartha Sandipani Commentary of Chakrapanidatta. Varanasi: Chaukhambha Sanskrit Series;2003.p Patient Information Leaflet for PID Royal College of Obstetrics and Gynaecologists. 7. Acharya SB, Frotan MH, Goel RK, Tripathi SK, Das PK. Pharmacological actions of Shilajit. Indian Journal of Experimental Biology. 1988; 26: Journal of Ayurveda and Holistic Medicine January, 2014 Volume 2 Issue 1 31

6 8. Bhaumik S, Chattapadhay S, Ghosal S. Effects of Shilajit on mouse peritoneal macrophages. Phytotherapy Research. 1993; 7: Bhattacharya SK. Shilajit attenuates streptozotocin induced diabetes mellitus and decrease in pancreatic islet superoxide dismutase activity in rats. Phytotherapy Research. 1995; 9(1): Velmurugan Vivek. et al. Immunomodulatory activities of the aqueous extracts of some Indian medicinal plants. Journal of Pharmaceutical and Biomedical Sciences (JPBMS). 2010; 1 (01), Trivedi NA, Mazumdar B, Bhatt JD, Hemavathi KG. Effect of shilajit on blood glucose and lipid profile in alloxan-induced diabetic rats. Indian Journal of Pharmacology. 2004;36:373-6 Cite this article as: Vishwesh B.N.. Shobha Bhat. A clinical study to evaluate the role of shivagutika in pelvic inflammatory disease. Journal of Ayurveda and Holistic Medicine (JAHM). 2014; 2(1).p Source of support: Nil, Conflict of interest: None Declared. Journal of Ayurveda and Holistic Medicine January, 2014 Volume 2 Issue 1 32